pressure-injectable-cvc-ifu.pdf

7/27/2019 pressure-injectable-cvc-ifu.pdf

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Venous Access | Critical Care

Pressure InjectableCVC Product


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Arrow International, Inc.

2009 Arrow International, Inc. All rights reserved. Printed in the USA.

An issued or revision date for these instructions is included for user information. In the event two years haveelapsed between this date and product use, the user should contact Arrow International, Inc. to see if additionalproduct information is available.

Issued Date: September 2009Rx only.


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PRESSURE INJECTABLE CVC | iii

Table of Contents

Product Description 1Indications / Contraindications . . . . . . . . . . . . . . . . . . . . . . . . 1

Central Venous Catheter Warnings and Precautions 1

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Guidewire / SWG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Tissue Dilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Pressure Injection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Possible Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Accessory Component Instructions 4

Arrow Advancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Arrow Raulerson Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Catheter Clamp and Fastener . . . . . . . . . . . . . . . . . . . . . . . . . 5

Catheter Stabilization Device . . . . . . . . . . . . . . . . . . . . . . . . . 6

Dressing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Echogenic Needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Guidewire / SWG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Luer-Activated Connector . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Maximal Barrier Drape . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Protected Needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

SharpsAway II Locking Disposal Cup . . . . . . . . . . . . . . . . . . . . . 10

Staple Anchoring Device . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Pre-CVC Insertion & Patient Assessment Activities 10

Procedural Pause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Preparing for Catheter Insertion . . . . . . . . . . . . . . . . . . . . . . . 11

Prep Puncture Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Flush Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

For reference literature concerning patient assess-

ment, clinician education, insertion techniques

and potential complications associated with this

procedure refer to Arrow International, Inc. website:www.arrowintl.com

For convenience, procedural and general Warnings

and Precautions are listed at the beginning of

the instructions. Please review all content before

performing the procedure.


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iv | PRESSURE INJECTABLE CVC

Catheter Insertion Instructions 11

Gain Initial Venous Access . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Verify Venous Access. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Guidewire / SWG Insertion . . . . . . . . . . . . . . . . . . . . . . . . 12

Catheter Advancement . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Complete Catheter Insertion . . . . . . . . . . . . . . . . . . . . . . . . . 13

Documentation 13

Pressure Injection Instructions 14

Care and Maintenance 14

Dressing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Maintain Catheter Patency . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Catheter Removal 15


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| 1

Pressure InjectableCentral Venous Catheter (CVC) Product

Product DescriptionTe Arrow Pressure Injectable CVC is a central venous catheter

manufactured with medical grade, flexible polyurethane. A Pressure

Injectable CVC may vary from two to four noncommunicating

lumens. Te catheter has a soft Blue Flexip that is more pliable

than the catheter body. Lumens are connected to separate color-

coded extension lines which have hubs on the end that are standard

Luer-Lock. Centimeter markings referenced from the tip areplaced along length of indwelling catheter body to facilitate proper

positioning. Te kit components assist the clinician in maintaining

maximal sterile barrier precautions (where provided).

Indications:Te Arrow CVC is indicated to provide short-term (< 30 days)

central venous access for treatment of diseases or conditions requiring

central venous access including, but not limited to:

multiple infusions of fluids, medications, or chemotherapy

infusion of fluids that are hypertonic, hyperosmolar, or have

divergent pH values

frequent blood sampling or blood/blood component infusions

infusion of incompatible medications

central venous pressure monitoring

lack of usable peripheral IV sites

replacement of multiple peripheral sites for IV access

injection of contrast media

When used for pressure injection of contrast media, do not

exceed the maximum indicated flow rate for each catheter

lumen. Te maximum pressure of power injector equipment

used with pressure injectable CVC may not exceed 400 PSI.

Contraindications:None known. See additional labeling for product specific

contraindications.

Central Venous Catheter

Warnings and Precautions:

Do not place the catheter into or allow it to remain in the rightatrium or right ventricle (refer to Figure 1).

Figure 1

General Warnings and PrecautionsWarnings:

1. Read all package insert warnings, precautions, andinstructions prior to use. Failure to do so may result in

severe patient injury or death.

2. Practitioners must be aware of complications associated

with central vein catheters including but not limited to:

cardiac tamponade secondary to vessel wall, atrial or

ventricular perforation, pleural and mediastinal injuries,

air embolism, catheter embolism, catheter occlusion,

thoracic duct laceration, bacteremia, septicemia,thrombosis, inadvertent arterial puncture, nerve damage,

hematoma, hemorrhage, and dysrhythmias.

3. Do not place Central Venous Catheter (CVC) or

Peripherally Inserted Central Catheter (PICC) into or allow

them to remain in the right atrium or right ventricle.

X-ray exam or other method in compliance with hospital/

institutional protocol must show catheter tip located in

right side of mediastinum in the Superior Vena Cava (SVC)

above its junction with right atrium and parallel to vesselwall and its distal tip positioned at a level above either

azygos vein or carina of the trachea, whichever is better

visualized. Although cardiac tamponade secondary

to pericardial effusion is uncommon, there is a high

mortality rate associated with it. Improper advancement

of guidewire into the heart has also been implicated in

causing cardiac perforation and tamponade. For femoral

vein approach, catheter should be advanced into vessel

so catheter tip lies parallel to vessel wall and does notenter right atrium.


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4. Ensure catheter tip has not entered the heart or no longerlies parallel to vessel wall by performing an x-ray exam orother method in compliance with hospital/institutionalprotocol. If catheter position has changed, immediatelyre-evaluate.

5. Practitioners must be aware of the potential forentrapment of guidewire by any implanted device incirculatory system (i.e., vena cava filters, stents). Reviewpatients history before catheterization procedure toassess for possible implants. Care should be takenregarding length of guidewire inserted. It is recommendedthat if patient has a circulatory system implant, catheterprocedure be done under direct visualization to minimizethe risk of guidewire entrapment.

6. Choose appropriate sized catheter for size of vessel to becannulated.

7. Catheter tip must be located in central circulation whenadministering > 10% glucose solution, total parenteralnutrition, continuous vesicant therapy, infusates withpH less than 5 or greater than 9, and infusates with anosmolality above 600 mOsm/L, or any medication knownto be irritating to vessels proximal to the vena cava.

8. Do not leave open needles or uncapped, unclampedcatheters in central venous puncture site. Air embolismcan occur with these practices.

9. Use only securely tightened Luer-Lock connectionswith any Central Venous Access Device (CVAD) to guardagainst inadvertent disconnect.

10. Use Luer-Lock connectors to help guard against airembolism and blood loss.

11. Pulsatile flow is usually an indicator of inadvertent

arterial puncture.

Cautions:1. The product is designed for single use only.

2. Do not resterilize or reuse.

3. Do not use if package has been previously opened ordamaged.

4. Do not alter the catheter, guidewire, or any other kit/setcomponent during insertion, use, or removal (except as

instructed).5. Procedure must be performed by trained personnel well

versed in anatomical landmarks, safe technique, andpotential complications.

6. Assess patient for heparin sensitivity. Heparin-InducedThrombocytopenia (HIT) has been reported with use ofheparin flush solutions.

7. Do not routinely apply prophylactic topical antimicrobialor antiseptic ointment or cream to the insertion site of

central venous catheters because of the potential risk topromote fungal infections and antimicrobial resistance.

8. Temporarily shut off remaining port(s) through whichsolutions are being infused before blood sampling.

9. Blood aspirate color is not always a reliable indicator ofvenous access.

10. Do not reinsert needle into introducer catheter to reducerisk of catheter embolism.

11. Maintain insertion site with regular meticulous redressingusing aseptic technique.

12. Activate safety feature of safety scalpel (if provided) whennot in use to minimize the risk of sharps injury.

13. Perform hand hygiene before and immediately after all

clinical procedures and before and after donning andremoval of gloves.

14. Properly handle and dispose of sharps in sharps containerin accordance with US OSHA or other governmentalstandards for blood borne pathogens and/or hospital/institutional policy.

15. Hands must remain behind the needle at all times duringuse and disposal.

16. Use universal blood and body-fluid precautions in thecare of all patients due to the risk of exposure to HIV(Human Immunodeficiency Virus) or other blood bornepathogens.

Catheter Warnings and PrecautionsWarnings:1. Only utilize catheters indicated for high pressure injection

applications for such applications. Utilizing catheters notindicated for high pressure applications can result ininter-lumen crossover or rupture with potential for injury.

2. Do not apply excessive force in placing or removingcatheter. Excessive force can cause catheter breakage. Ifplacement or withdrawal cannot be easily accomplished,an x-ray should be obtained and further consultationrequested.

3. Do not secure, staple, and/or suture directly to outside

diameter of catheter body or extension lines to minimizethe risk of cutting or damaging the catheter or impedingcatheter flow. Secure only at indicated stabilizationlocations.

4. Do not cut catheter to alter catheter length.

5. Do not attach catheter clamp and fastener (whereprovided) until either guidewire or placement wire isremoved.

6. Do not use scissors to remove dressing to minimize therisk of cutting catheter.


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PRESSURE INJECTABLE CVC | 3

7. Open catheter clamp prior to infusion through lumen

to minimize the risk of damage to extension line from

excessive pressure.

8. Practitioners should remove slide clamp(s), where

provided, when not in use. Slide clamp(s) may beinadvertently removed and aspirated by children or

confused adults.

9. Do not routinely replace central venous catheters solely

for the purpose of reducing incidence of infection.

10. Do not use guidewire techniques to replace catheters in

patient suspected of having catheter-related infection.

11. Residual catheter track remains an air entry point until

completely sealed, occlusive dressing should remain inplace for at least 24 - 72 hours dependent upon amount

of time catheter was indwelling.

Cautions:1. Check ingredients of prep sprays and swabs before using.

Some disinfectants used at catheter insertion site contain

solvents which can attack the catheter material. Alcohol

and acetone can weaken the structure of polyurethane

materials. These agents may also weaken the adhesivebond between catheter stabilization device and skin.

Acetone: Do not use acetone on catheter surface.

Alcohol: Do not use alcohol to soak catheter surface or

to restore catheter patency.

Take care when instilling drugs containing high

concentration of alcohol. Allow insertion site to dry

completely prior to applying dressing.

2. Ensure catheter patency prior to injection. Donot use syringes smaller than 10 mL (a fluid filled

1 mL syringe can exceed 300 psi), to minimize the risk of

intraluminal leakage or catheter rupture.

3. Remove catheter clamp and fastener (where provided)

prior to attempting a catheter exchange procedure.

4. Do not exert excessive force while removing the catheter,

to minimize the risk of catheter breakage.

5. Continuously monitor indwelling catheter for: desired flow rate

security of dressing

adherence of stabilization device to skin and

connection to catheter

correct catheter position; use centimeter markings to

identify if catheter position has changed

secure Luer-Lock connection(s)

6. Minimize catheter manipulation throughout procedure tomaintain proper catheter tip position.

7. Inject a small amount of radiopaque dye to locatecatheter tip if difficulty is encountered in visualizing thecatheter tip.

Guidewire / SWG Warnings and PrecautionsWarnings:1. Do not cut guidewire to alter length.

2. Do not withdraw guidewire against needle bevel tominimize the risk of possible severing or damaging ofguidewire.

3. Do not use excessive force when introducing guidewireor tissue dilator as this can lead to vessel perforation and

bleeding.4. Passage of guidewire into the right heart can cause

dysrhythmias, right bundle branch block, and aperforation of vessel, atrial, or ventricular wall.

5. Do not apply undue force on guidewire to minimize therisk of possible breakage.

6. Do not apply excessive force in removing guidewire orcatheter. If withdrawal cannot be easily accomplished, avisual image should be obtained and further consultationrequested.

7. Do not cut guidewire with scalpel.

Position cutting edge of scalpel away from guidewire.

Activate safety feature of safety scalpel (whereprovided) once cutaneous puncture site is enlarged,to minimize the risk of cutting the guidewire (refer toFigure 28).

8. Do not aspirate with guidewire in place or air will enter

syringe.Caution:1. Maintain a firm grip on guidewire at all times. Keep

sufficient guidewire length exposed at hub for handlingpurposes. A non-controlled guidewire can lead to wireembolism.

2. If resistance is encountered when attempting to removeguidewire after catheter placement, guidewire maybe kinked about tip of catheter within vessel (refer to

Figure 29).

Tissue Dilator WarningsWarnings:1. Do not leave tissue dilator in place as an indwelling

catheter. Leaving tissue dilator in place puts patient at riskfor possible vessel wall perforation.

2. Do not use excessive force when introducing guidewire

or tissue dilator as this can lead to vessel perforation andbleeding.


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Pressure Injection Warnings and PrecautionsWarnings:1. Assess each patient for appropriateness of a pressure

injection procedure. Pressure injection procedures mustbe performed by trained personnel well versed in safetechnique and potential complications.

2. Obtain a visual image to confirm catheter tip positionprior to each pressure injection.

3. Ensure patency of each lumen of catheter prior topressure injection to minimize the risk of catheter failureand/or patient complications.

4. Discontinue pressure injections at first sign ofextravasation or catheter deformation. Followhospital/institutional protocol for appropriate medicalintervention.

Cautions:1. Do not exceed ten (10) injections or catheters maximum

recommended flow rate located on product labeling andcatheter luer hub to minimize the risk of catheter failureand/or tip displacement.

2. Warm contrast media to body temperature prior topressure injection to minimize the risk of catheter failure.

3. Pressure limit settings on injector equipment maynot prevent over pressurizing an occluded or partiallyoccluded catheter.

4. Use appropriate administration set tubing betweencatheter and pressure injector equipment to minimize the

risk of catheter failure.5. Follow the contrast media manufacturers specified

instructions for use, contraindications, warnings, andprecautions.

Possible Complications (but not limited to): cardiac tamponade secondary to vessel wall, atrial or

ventricular perforation

pleural injury mediastinal injury

air embolism nerve injury

catheter embolism thoracic duct laceration

bleeding / hemorrhage occlusion

bacteremia septicemia

thrombosis inadvertent arterial puncture

hematoma dysrhythmias

fibrin sheath formation

exit site infection vessel erosion catheter tip malposition

Accessory Component InstructionsReview the list of components that will be utilized before

beginning the Arrow Pressure Injectable CVC insertion

procedure. Kits / Sets may not contain all accessory

components detailed in this section. Become familiar withinstructions for each individual component before beginning

the actual insertion procedure.

Arrow Advancer:Arrow Advancer is used to straighten J Tip of Spring-Wire Guide (SWG) for

introduction of guidewire into Arrow Raulerson Syringe or a needle.

Using your thumb, straighten the J by retracting SWG into theArrow Advancer (refer to Figures 2 and 3).

Figure 2

Figure 3

When tip is straightened, SWG is ready for insertion. Centimetermarks on SWG are referenced from J ip: one band indicates10 cm, two bands 20 cm, and three bands 32 cm.

Place tip of Arrow Advancer with J retracted into the hole

in rear of Arrow Raulerson Syringe plunger (refer to Figure 4)or introducer needle.


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Simple Straightening Tube Technique:

Te straightening tube portion of the Arrow Advancer can bedisconnected from the unit and used separately.

Separate Arrow Advancer tip or straightening tube from blueArrow Advancer unit.

Prepare for insertion by sliding plastic tube over J to straighten,if J ip portion of SWG is used.

Advance SWG in routine fashion to desired depth.

Arrow Raulerson Syringe:Arrow Raulerson Syringe is used in conjunction with Arrow Advancer

for SWG insertion.

Warning: Do not withdraw guidewire against needle bevel to

minimize the risk of possible severing or damaging of

guidewire.

Warning: Do not aspirate with guidewire in place or air may enter

syringe.

Caution: Blood aspirate color is not always a reliable indicator of

venous access.Caution: Do not reinfuse blood to minimize the risk of blood leakage

from rear (cap) of syringe.

Caution: Maintain firm grip on guidewire at all times. Keep sufficient

guidewire length exposed at hub for handling purposes. A

non-controlled guidewire can lead to wire embolism.

Insert introducer needle attached to ArrowRaulerson Syringeinto vessel and aspirate.

Vessel may be prelocated with a 22 Ga. locater needle.

For pressure wave form transduction, a separately packagedtransduction probe is available.

Straighten SWG J.

Advance SWG through ArrowRaulerson Syringe into vessel todesired depth.

Hold SWG in place and remove introducer needle and Arrow

Raulerson Syringe.

Catheter Clamp and Fastener:Catheter Clamp and Fastener are used to secure catheter when an additional

securement site other than catheter hub is required for catheter stabilization.

After SWG has been removed and necessary lines have beenconnected or locked, spread wings of rubber clamp and position

on catheter making sure catheter is not moist, as required, tomaintain proper tip location (refer to Figure 7).

Figure 4 Advance SWG into Arrow Raulerson Syringe approximately

10 cm until it passes through syringe valves (refer to Figure 5) orinto introducer needle.

Figure 5

Raise thumb and pull Arrow Advancer approximately 4 - 8 cmaway from Arrow Raulerson Syringe or introducer needle.Lower thumb onto Arrow Advancer and while maintaining afirm grip on SWG, push assembly into syringe barrel to furtheradvance SWG. Continue until SWG reaches desired depth (referto Figure 6).

Figure 6


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Figure 7

Snap rigid fastener onto catheter clamp (refer to Figure 8).

Figure 8

Secure catheter to patient by stapling or suturing catheter clampand fastener together to skin, using side wings to minimize therisk of catheter migration (refer to Figure 9).

Figure 9

Catheter Stabilization Device:A catheter stabilization device should be used in accordance with manufacturersinstructions for use.

Caution: Minimize catheter manipulation throughout procedure tomaintain proper catheter tip position.

Cleanse and prep anticipated dressing site per hospital/institutional protocol.

Apply skin prep (where provided) to coat skin and maximizeadherence.

Allow to dry thoroughly.

Position catheter stabilization device appropriate distance fromcatheter insertion site to permit ease of insertion site care andmaintenance.

Secure catheter by using the primary suture hub.

Place suture hub wings over posts and press down (refer toFigure 10). Snap retainer wings to closed position to securesuture hub (refer to Figure 11).

Figure 10

Figure 11

Remove paper backing from one half of catheter stabilizationdevice pad and press onto dry, prepared skin. Repeat process forother half.

Complete sterile insertion site dressing according to establishedhospital/institutional protocol.

Document dressing application on patients chart.

Replace dressing per hospital/institutional protocol. Catheter

stabilization device should be replaced at least every 7 days toensure maximum adherence.


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Dressing:A transparent dressing should be used in accordance with manufacturers

instructions for use.

Prepare site. Allow all preps to dry completely.

Peel liner from dressing to expose adhesive.

Adhere center of transparent window over insertion site, whileholding notched portion off the skin (refer to Figure 12).

Figure 12

Overlap softcloth tabs under catheter to form a tight seal aroundcatheter hub and lumens (refer to Figure 13).

Figure 13

Press dressing into place.

Slowly remove frame while smoothing down dressing edges.

Smooth dressing from center toward edges, use firm pressure toenhance adhesion (refer to Figure 14).

Figure 14

Use sterile tape strips to secure hub, lumens, and/or tubing (refer

to Figure 15).

Figure 15

Label dressing according to protocol.

Refer to individual manufacturers instructions for more information

and specific detailed instructions for dressing removal (not included).

Echogenic Needle:

An echogenic needle is used to provide greater needle visibility under

ultrasound. The needle tip is enhanced for approximately 1 cm for clinician toidentify exact needle tip location when puncturing the vessel under ultrasound.

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Guidewire / SWG:

Kits/Sets are available with a variety of guidewires/SWGs. Guidewires are

provided in different diameters, lengths, and tip configurations for specific

insertion techniques. Become familiar with the guidewire(s) to be used with the

specific technique before beginning the actual CVC insertion procedure.

Image guidance may be used to gain initial venous access.

Luer-Activated Connector:

A Luer-Lock connector is use to minimize the risk of accidental disconnects and

potential for air embolism.

Caution: Do not use needles in connector unless specifically indicated.

Caution: Do not cap connector unless specifically indicated.

Caution: Check for clamping requirement to prevent fluid movement

prior to connector disconnect and use.

General Guidelines for Connector Use:

Use aseptic technique. Remove connector from packaging.

Inspect for integrity.

If applicable:

prime in accordance with hospital/institutional protocol

expel air

Disinfect desired extension set or venous access device; makesure to rotate swab to ensure cleaning of septum and threads.

Attach connector to desired extension set or venous access device.

Secure connector. If using a rotating luer connector, make surethat the spin collar is tightened.

Position connector to achieve the most comfortable position onthe patients skin.

Access: Swab connector with desired disinfectant in accordancewith hospital/institutional and connector manufacturer protocol.

Utilize only fully primed syringe or administration set.

Disconnect from venous access device or administration set,grasp connector/cap and twist until loose.

Flush after each use with normal saline or in accordance withhospital/institutional protocol.

Repeat above steps for subsequent connections.

Refer to individual manufacturers instructions for specific connectordetails, including priming volumes, dead space, and flow rates.

Maximal Barrier Drape:

Drape(s) provide a maximal sterile barrier. Follow the CDC Category 1A

Recommendation.

Unfold the Maximal Barrier Drape:

Peel off fenestration backing (refer to Figure 16).

Figure 16

Position fenestration over intended insertion site (refer to

Figure 17).

Figure 17

Unfold width (refer to Figure 18).

b

a

Figure 18



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Unfold towards head (refer to Figure 19).

Figure 19

Unfold towards hand (refer to Figure 20).

Figure 20

Perform sterile procedure (refer to Figure 21).

Figure 21

Removal procedure: ear along seam (refer to Figure 22).

TO

REMOVEDRAPE

TEARALONG

SEA

M

Figure 22

Protected Needle:See individual manufacturers instructions for product use, when used as a singleproduct and not as a kit component.

Warning: Hands must remain behind needle at all times during useand disposal.

Caution: Make sure all needles are used in accordance with OSHA and

hospital/institutional safety protocols.

Caution: Do not attempt to override or defeat the safety lockingmechanism of a protected needle.

Caution: Discard in an approved sharps collector in accordance withapplicable regulations and hospital/institutional policy.

General Guidelines for Protected Needle Use: Aspirate medication into syringe using aseptic technique.

If necessary to transport filled syringe to point of administration,use safe, passive recapping technique to cover needle beforetransport to point of use. In accordance with OSHA standards,such recapping must be accomplished by a one-handedtechnique, i.e., do not hold needle shield during recappingprocess.

Administer injection following established technique.

Immediately activate needle protection device upon withdrawalfrom patient by pushing lever arm completely forward until

needle tip is fully covered (see Figure 23).

Figure 23

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10 |

Visually confirm lever arm has fully advanced and needle tip iscovered. If unable to activate, discard immediately into approvedsharps collector.

Activation of protective mechanism may cause minimal splatter

of fluid that may remain on needle after injection. After single use, discard in an approved sharps collector in

accordance with applicable regulations and hospital/institutionalpolicy. For greatest safety, use a one-handed technique andactivate away from self and others.

SharpsAway II Locking Disposal Cup:The SharpsAway II Locking Disposal Cup is used for disposal of needles(15 Ga. - 30 Ga.).

Using one-handed technique, firmly push needles into disposalcup holes (refer to Figure 24).

Secureneedles for

final disposal

Figure 24

Once placed into disposal cup, needles will be automaticallysecured in place so that they cannot be reused.

Discard entire cup, at completion of procedure, into an approvedsharps container.

Caution: Do not attempt to remove needles that have been placedinto SharpsAway II Locking Disposal Cup. These needlesare secured in place. Damage may occur to needles if theyare forced out of disposal cup.

Where provided, a foam SharpsAway system may be utilized bypushing needles into foam after use.

Caution: Do not re-use needles after they have been placed into thefoam SharpsAway system. Particulate matter may adhereto needle tip.

Staple Anchoring Device:Staples offer an alternative for catheter stabilization.

Warning: Do not secure, staple, and/or suture directly to outsidediameter of catheter body or extension lines to minimizethe risk of cutting or damaging the catheter or impeding

catheter flow. Secure only at indicated stabilizationlocations.

Position thumb and index finger of dominant hand on indentedsurface of staple anchoring device.

Pass staple point through eye of catheter suture hub (refer toFigure 25).

Figure 25

ent skin and position with hub eye between staple opening.

Firmly squeeze anchoring device together to close staple andsecure catheter to skin (refer to Figure 26).

Figure 26

Repeat procedure through other suture eyes, if applicable.

Discard anchoring device upon completion.

Pre-CVC Insertion &Patient Assessment Activities

A Suggested ProcedureWarning: Read all package insert warnings, precautions, and

instructions prior to use. Failure to do so may result in severepatient injury or death.

Clinical assessment of patient must be completed to ensure no contraindicationsexist e.g. allergies. This device is not recommended for use in the presence ofdevice related infections or previous/current thrombosis.

Perform hand hygiene as required.

A procedural checklist is included in many Arrow products. Check individualproduct labeling to see if one is included.



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Procedural Pause:1. Verify physician order:

Confirm correct patient.

Confirm correct diagnosis. Confirm correct procedure.

Physician order must include post placement assessment ofcatheter tip placement (direct visualization technique or othermethod in compliance with hospital/institutional protocol).

2. Educate patient: Explain procedure to patient. Make sureinformation is presented with respect to patients level ofunderstanding, culture, and language.

3. Have informed consent signed, if required.4. Identify insertion vein:

Identify appropriate vein for insertion.

Use direct visualization technologies, e.g. ultrasound orfluoroscopy, if available; and assess vein health.

5. Position patient as appropriate for insertion site:

Subclavian or jugular approach: Place patient in slightrendelenburg position as tolerated to reduce the risk of air

embolism and enhance venous filling. If femoral approach is used, place patient in supine position.

6. Prepare work area.

Preparing for Catheter Insertion: Perform hand hygiene as required:

before and immediately after all clinical procedures

before and after donning and removal of gloves

Caution: Use universal blood and body-fluid precautions in the careof all patients due to the risk of exposure to HIV (HumanImmunodeficiency Virus) or other blood borne pathogens.

Caution: Properly handle and dispose of sharps in sharps container inaccordance with US OSHA or other governmental standardsfor blood borne pathogens and/or hospital/institutionalpolicy.

Clinicians should use sterile technique, maximal sterile barrierprecautions throughout the procedure, and dress in protective

clothing: mask eye protection

sterile gown sterile gloves

hair cover

Prep Puncture Site:1. Prep puncture site with appropriate antiseptic/agent.

2. Drape puncture site.

See unfolding instructions for Maximal Barrier Drape (where provided) underAccessory Component Instructions section.

3. Perform skin wheal using desired needle (25 Ga. or 22 Ga.) withlocal anesthetic.

4. Dispose of needle.

In kits where provided, the SharpsAway II Locking Disposal

Cup is used for disposal of needles (15 Ga. - 30 Ga.).See SharpsAway II Locking Disposal Cup under Accessory ComponentInstructions section.

Caution: Do not attempt to remove needles that have been placedinto SharpsAway II Locking Disposal Cup. These needlesare secured in place. Damage may occur to needles if theyare forced out of disposal cup.

Caution: Do not re-use needles after they have been placed into thefoam SharpsAway system. Particulate matter may adhere

to needle tip.

Flush Catheter:1. Flush each lumen with sterile saline solution, to establish patency

and prime lumen(s).

2. Clamp or attach injection site cap(s) to extension line(s) tocontain saline within lumen.

3. Leave distal extension line uncapped for SWG passage.

Warning: Do not cut catheter to alter length.

Catheter Insertion Instructions

Gain Initial Venous Access:Warning: Do not leave open needles or uncapped, unclamped

catheters in central venous puncture site. Air embolism canoccur with these practices.

1. Insert introducer needle or catheter/needle with attached syringeor Arrow Raulerson Syringe (where provided) into vein and

aspirate. NOTE: If larger introducer needle is used, vessel may be pre-located with

22 Ga. locater needle and syringe.

See Arrow Raulerson Syringe under Accessory Component Instructions section.

2. Remove locater needle.

Caution: Blood aspirate color is not always a reliable indicator ofvenous access.

Caution: Do not reinsert needle into introducer catheter to reduce

risk of catheter embolism.

Verify Venous Access:Because of the potential for inadvertent arterial placement, one of the followingtechniques should be utilized to verify venous access:

1. Central Venous Waveform: Insert fluid primed blunt tip pressure transduction probe into

rear of plunger and through valves of the Arrow RaulersonSyringe and observe for central venous pressure waveform.

Remove transduction probe if using Arrow RaulersonSyringe.

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Observe for central venous pressure waveform obtainedby a calibrated pressure transducer attached directly to theintroducer needle/catheter (refer to Figure 27).

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0

Figure 27

2. Pulsatile Flow (if hemodynamic monitoring equipment is notavailable):

Use transduction probe to open syringe valving system ofArrow Raulerson Syringe and observe for pulsatile flow.

Disconnect syringe from needle and observe for pulsatileflow.

Warning: Pulsatile flow is usually an indicator of inadvertent arterial

puncture.

Guidewire / SWG Insertion:1. Straighten J of SWG by using a straightening tube or

Arrow Advancer (where provided).

See Arrow Advancer under Accessory Component Instructions section.

2. Insert tip of SWG into plunger of Arrow Raulerson Syringe orinto introducer needle.

3. Advance SWG through Arrow Raulerson Syringe

or introducer needle into vein to desired depth. Advancement of J ip through Arrow Raulerson Syringe

may require a gentle rotating motion.

Advance SWG until triple band mark reaches rear of ArrowRaulerson Syringe plunger.

4. Use centimeter markings on SWG as a reference to assist indetermining how much guidewire has been inserted.

NOTE: If guidewire has three sets of markings, they will be located as

follows: One band - 10 cm from J Tip

Two bands - 20 cm from J Tip

Three bands - 32 cm from J Tip

NOTE: When guidewire is used in conjunction with the Arrow Raulerson

Syringe (fully aspirated) and a 2-1/2 inch introducer needle, the following

positioning references can be made:

20 cm mark entering back of plunger = guidewire tip is at end of needle

32 cm mark entering back of plunger = guidewire tip is approximately10 cm beyond end of needle

Caution: Maintain firm grip on guidewire at all times. Keep sufficientguidewire length exposed at hub for handling purposes. Anon-controlled guidewire can lead to wire embolism.

Warning: Do not aspirate with guidewire in place or air may enter

syringe.Caution: Do not reinfuse blood to minimize the risk of blood leakage

from rear (cap) of syringe.

Warning: Do not withdraw guidewire against needle bevel tominimize the risk of possible severing or damaging ofguidewire.

5. Remove introducer needle and Arrow Raulerson Syringe (orcatheter) while holding SWG in place.

6. Use centimeter markings on SWG to adjust indwelling lengthaccording to desired depth of indwelling catheter placement.

7. Enlarge cutaneous puncture site with cutting edge of scalpel,where provided, positioned away from SWG.

Warning: Do not cut guidewire to alter length.

Warning: Do not cut guidewire with scalpel.

Position cutting edge of scalpel away from guidewire.

Activate safety feature of safety scalpel (where provided)

once cutaneous puncture site is enlarged, to minimize therisk of cutting the guidewire (refer to Figure 28).

Figure 28

8. Use tissue dilator to enlarge puncture site as required.

Warning: Do not leave tissue dilator in place as an indwelling catheter

to minimize the risk of possible vessel wall perforation.

Catheter Advancement:1. Tread tip of catheter over SWG. Sufficient SWG length must

remain exposed at hub end of catheter to maintain a firm grip onSWG.

2. Grasping near skin, advance catheter into vein with slighttwisting motion.

Warning: Do not attach catheter clamp and fastener (where provided)until either guidewire or placement wire is removed.



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3. Using centimeter marks on catheter as positioning referencepoints, advance catheter to final indwelling position.

NOTE: Centimeter marking symbology is referenced from catheter tip.

numerical: 5, 15, 25, etc.

bands: each band denotes a 10 cm interval, with one band indicating10 cm, two bands indicating 20 cm, etc.

dots: each dot denotes a 1 cm interval

4. Hold catheter at desired depth and remove SWG.

NOTE: Arrow catheters are designed to pass freely over SWG.

Caution: If resistance is encountered when attempting to removeguidewire after catheter placement, guidewire maybe kinked about tip of catheter within vessel (refer to

Figure 29).

Figure 29

In this circumstance, pulling back on SWG may result inundue force being applied resulting in SWG breakage.

If resistance is encountered, withdraw catheter relative toSWG about 2-3 cm and attempt to remove SWG.

If resistance is again encountered remove SWG and cathetersimultaneously.

Warning: Do not apply undue force on guidewire to minimize the risk

of possible breakage.

5. Verify entire SWG is intact upon removal.

Complete Catheter Insertion:1. Check lumen placement by attaching a syringe to each extension

line and aspirate until free flow of venous blood is observed.

2. Flush lumen(s) to completely clear blood from catheter.

3. Connect all extension line(s) to appropriate Luer-Lock line(s)

as required. Unused port(s) may be locked through injectioncap(s) using standard hospital/institutional protocol.

Slide clamps are provided on extension lines to occlude flowthrough each lumen during line and injection cap changes.

Warning: Open catheter clamp prior to infusion through lumento minimize the risk of damage to extension line fromexcessive pressure.

4. Secure catheter to patient.

Where provided, a catheter clamp, fastener, catheterstabilization device, staples or suture may be used.

Use triangular juncture hub with side wings as primarysuture site

Catheter clamp and fastener should be utilized as a secondarysuture site as necessary.

Caution: Minimize catheter manipulation throughout procedure tomaintain proper catheter tip position.

See Catheter Clamp and Fastener, Staple Anchoring Device under AccessoryComponent Instructions section.

5. Ensure insertion site is dry before applying dressing. Apply skinprotectant as needed.

Caution: Do not routinely apply prophylactic topical antimicrobial orantiseptic ointment or cream to the insertion site of central

venous catheters because of the potential risk to promotefungal infections and antimicrobial resistance.

6. Assess placement of catheter tip in compliance with hospital/institutional protocol.

Warning: Do not place Central Venous Catheter (CVC) or PeripherallyInserted Central Catheter (PICC) into or allow them toremain in the right atrium or right ventricle. X-ray examor other method in compliance with hospital/institutionalprotocol must show catheter tip located in right side of

mediastinum in the Superior Vena Cava (SVC) above itsjunction with right atrium and parallel to vessel wall and

its distal tip positioned at a level above either azygos veinor carina of the trachea, whichever is better visualized.Although cardiac tamponade secondary to pericardialeffusion is uncommon, there is a high mortality rateassociated with it. Improper advancement of guidewireinto the heart has also been implicated in causing cardiacperforation and tamponade. For femoral vein approach,catheter should be advanced into vessel so catheter tip lies

parallel to vessel wall and does not enter right atrium.

7. If catheter tip is malpositioned, reposition, redress, and re-verify.

DocumentationHospitals/institutions must establish a permanent medicalrecord that documents the entire procedure, based upontheir policy, procedures, and Best Practices. The actualformat can differ from institution to institution. Report any

product defects/failures to organization risk management,manufacturers, and appropriate regulatory agencies.

Documentation generally includes (but is not limited to)the following information:

1. Device specifics:

type, brand and lot number

length and size of Vascular Access Device (VAD)

internal/external catheter length

antimicrobial or not

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2. Procedure specifics:

time out or procedural pause

informed consent, as required

date, time of insertion, insertion site, number and site

attempts, inserters identification use of visualization and guidance technologies

site preparation and technique

3. Patient assessment and response:

pertinent dx, assessment, vital signs

understanding of procedure, patients response to procedure

complications and barriers to care

4. Terapy specifics:

type of therapy, drug dose, rate, time route and method of administration

laboratory specimen collected

5. Visual confirmation:

verification of appropriate tip location prior to initial use

6. Monitor patient for post catheter insertion complications.

Pressure Injection InstructionsUse sterile technique.

Warning: Obtain a visual image to confirm catheter tip position priorto each pressure injection.

1. Remove injection cap from appropriate extension line ofcatheter.

2. Check for catheter patency:

Attach 10 mL syringe filled with sterile normal saline.

Aspirate catheter for adequate blood return. Vigorously flush catheter.

Warning: Ensure patency of each lumen of catheter prior to pressureinjection to minimize the risk of catheter failure and/orpatient complications.

3. Detach syringe.

4. Attach pressure injection administration set tubing toappropriate extension line of catheter according to manufacturers

recommendations.Caution: Do not exceed ten (10) injections or catheters maximum

recommended flow rate located on product labeling andcatheter luer hub to minimize the risk of catheter failureand/or tip displacement.

5. Inject contrast media in accordance with hospital/institutional protocol.

Caution: Warm contrast media to body temperature prior to pressureinjection to minimize the risk of catheter failure.

6. Disconnect catheter from pressure injector equipment.

7. Flush catheter using 10 mL syringe or larger filled with sterilenormal saline.

8. Disconnect syringe and replace with sterile injection cap oncatheter extension line.

NOTE: Do not exceed ten (10) pressure injections.

Care and Maintenance

Dressing:Replace dressing according to hospital/institutional policies, procedures, andpractice guidelines. Change immediately if the integrity becomes compromisede.g. dressing becomes damp, soiled, loosened, or no longer occlusive.

Caution: Maintain insertion site with regular meticulous redressing

using aseptic technique.

Consult manufacturers recommendations for dressing specifics.

ransparent semipermeable membrane dressing should bechanged every 7 days.

Gauze and tape should be changed every 48 hours.

Label dressing with type, size, and length of catheter; date andtime; and initials of the clinician performing dressing change.

Maintain Catheter Patency:Maintaining central venous catheter patency shall be done in accordance withhospital/institutional policies, procedures, and practice guidelines. All personnelwho care for patients with central venous catheters must be knowledgeableabout effective management to prolong catheters dwell time and prevent injury.

Perform hand hygiene as required.

1. Solution and frequency of flushing a venous access cathetershould be established in hospital/institutional policy.

2. Catheter patency is established and maintained by: flushing intermittently via syringe with heparinized saline or

preservative-free 0.9% sodium chloride continuous drip positive pressure device

3. Te amount of heparin: depends on physician preference, hospital/institutional protocol, patient condition

Caution: Assess patient for heparin sensitivity. Heparin-InducedThrombocytopenia (HIT) has been reported with use ofheparin flush solutions.

4. Te volume of flush solution should be: equal to at least twice the priming volume of the catheter

and any add-on devices

NOTE: Catheter priming volume is printed on product packaging.

Warning: Open catheter clamp prior to infusion through lumen

to minimize the risk of damage to extension line fromexcessive pressure.



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5. When using any central venous catheter for intermittent infusiontherapy, proper flushing (heparinization) using a positive-pressure flushing technique will help prevent occlusion.

NOTE: Neutral as well as positive displacement valve systems have also beenshown to help prevent occlusion.

6. Properly cleanse all valves with an appropriate antiseptic beforebeing accessed.

7. Te SASH or SAS method of flushing will help eliminateocclusions due to incompatible solutions:

Saline Administer drug Saline Heparin (if used)

Catheter Removal Procedure1. CVC removal shall be performed:

following order of authorized prescriber

in accordance with organizational policies, procedures, andpractice guidelines

2. A CVC shall be removed immediately upon patient assessmentfor:

suspected contamination i.e. when catheters are insertedduring a medical emergency or if adherence to aseptictechnique cannot be ensured

unresolved complication(s)

discontinuation of therapy

source of infection

Caution: Do not use guidewire techniques to replace catheters inpatient suspected of having catheter-related infection.

3. Place patient in supine position, as clinically indicated tominimize the risk of potential air embolism.

4. Remove dressing.

Warning: Do not use scissors to remove dressing, to minimize the riskof cutting catheter.

5. Remove sutures or staples; or open catheter stabilization deviceretainer wings and remove catheter from catheter stabilizationdevice posts.

6. Place gauze pad over insertion site and catheter.

7. Remove catheter by slowly pulling it parallel to skin. If resistanceis met while removing, catheter should not be forcibly removedand physician should be notified.

Caution: Do not exert excessive force while removing catheter; to

minimize the risk of catheter breakage.

8. Upon removal of catheter:

inspect for intact Blue Flexip or catheter tip

ensure entire catheter length has been removed

9. Apply direct pressure to site until hemostasis is achieved.

10. Apply alcohol swab to catheter stabilization device adhesive andgently lift pad off of skin (if applicable).

11. Dress insertion site. Sterile air occlusive dressing should beapplied and site assessed every 24 hours until site is epithelialized.

Warning: Residual catheter track remains an air entry point until

completely sealed, occlusive dressing should remain in

place for at least 24 - 72 hours dependent upon amount of

time catheter was indwelling.

12. Document catheter removal procedure on patients chart perhospital/institutional protocol.

Include:

catheter condition

presence of intact catheter tip

patients tolerance of the procedure

any interventions needed for removal

For reference literature concerning patient assessment,

clinician education, insertion techniques and potential

complications associated with this procedure refer to Arrow

International, Inc. website: www.arrowintl.com


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2400 Bernville Road, Reading, PA 19605 USA | 1-800-523-8446 1-610-378-0131 | 8 a.m. - 8 p.m. ES | www.arrowintl.com

C-45802-101A (9/09)

Documents

pressure-injectable-cvc-ifu.pdf